Deduction of BMDL of 3-MCPD and its esters for renal tubular hyperplasia effect based on BMD method

Abstract

ObjectiveTo calculate the lower limit of 95% confidence interval of benchmark dose （BMDL） of 3-monochloro-1，2-propanediol （3-MCPD） and its esters for renal tubular hyperplasia effect based on benchmark dose （BMD） method.MethodsThe data of the most sensitive endpoint of renal tubular hyperplasia in the 2-year chronic toxicity and carcinogenicity study of 3-MCPD were analyzed. BMD model and analysis were used by methods of frequentist， frequentist model averaging and Bayesian model averaging， respectively. Smooth dose response curve was obtained by fitting the nine conventional models， and then the optimal fitting model and BMDL10 estimation value were obtained.ResultsThe best data set was selected by comparing the conservative degree of results across different data sets. Under the same data set， the selection of restricted or non-restricted model parameters， and the selection of single model or model averaging， were key factors to affect the BMDL results of 3-MCPD and its esters. According to model fitting degree and conservative degree， BMDL10 of the most sensitive endpoint of renal tubular hyperplasia of 3-MCPD and its esters was 0.87 mg/kg·BW. The health based guidance value （HBGV） needs to be further determined by the BMDL10 with uncertainty factor.ConclusionThe results of this research could be applied for the risk assessment of 3-MCPD and its esters in key foods of China， and further provide scientific advice on the supervision and control of key foods based on the assessment results.

Keywords

• 3-mcpd and its esters
• benchmark dose （bmd）
• bayesian model averaging